Manager, Clinical Data Systems at Moderna

Cambridge, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

30 May, 26

Salary

174600.0

Posted On

01 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Data Management, ePRO, eConsent, IRT, EDC, Data Review, Technology Assessment, Regulatory Compliance, SOP Development, User Account Administration, Process Improvement, Vendor Assessment, System Validation, Project Management, Leadership, ICH GCP

Industry

Biotechnology Research

Description

The Role: The candidate in this position will assist in leading and organizing the clinical data management technology systems (ePRO, eConsent, IRT, EDC, data review, etc.) strategy, in collaboration with global clinical development and preferred strategic providers, to support the timely and efficient delivery of clinical data with high quality and within an allocated budget. Here's What You’ll Do Collaborating with Digital, Quality and relevant business functions to assess and identify new technologies to be used in support of clinical data management systems. Assessing and providing insight to current/latest technologies and changes in regulatory environments, proactively enabling a cutting-edge approach to clinical data systems technology and processes. Driving creation, maintenance, and execution of clinical data system SOPs, work instructions, best practices, and standards in support of clinical data systems in a growing, dynamic organization. Overseeing, supporting, and performing user account administration across multiple clinical data management technology platforms such as EDC, data review tools, and IRT. Providing oversight for a team of Clinical Data System Administrators in support of user access management and process improvement. Supporting technology improvement and innovation to enhance clinical data capture, management, and quality in compliance within applicable regulations and guidance. Liaising with clinical research organizations, vendors, and other third parties as necessary in support of clinical data system activities. Assisting in vendor assessments and qualifications of clinical trial data collection systems for compliance with regulatory requirements. Supporting validations of clinical data management systems and software to ensure appropriate and compliant implementation of new or upgraded technologies. Here’s What You’ll Need (Basic Qualifications) BS degree in Computer Science, Life Science or other technical field required, advanced degree desired. 4+ years of applicable clinical data systems and/or relevant drug development experience; global experience and experience in drug development strongly preferred. 2+ years of project management and leadership experience. Here’s What You’ll Bring to the Table (Preferred Qualifications) Knowledge of general clinical database programming principles, common software products, and technologies used in clinical trial data management. Knowledge and working experience with user account access and management in a compliant, regulated environment. Thorough command of FDA and ICH GCP regulations and industry standards applicable to drug development systems. Knowledge of regulations and best practices related to computer system validation, electronic records and signatures and data privacy. Outstanding verbal and written communication skills, in addition to excellent organizational skills Experience in regulatory GCP inspections/audits. This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs A holistic approach to well-being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investment opportunities to help you plan for the future Location-specific perks and extras The salary range for this role is $109,200.00 - $174,600.00(for positions that may be performed in California, the expected salary range is $148,800.00 - $171,200.00, which reflects the range permitted under California Labor Code requirements) . This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-NH1 - #LI-Remote Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home

Responsibilities

The manager will assist in leading and organizing clinical data management technology systems strategy, collaborating with global teams and providers to ensure timely, efficient, and high-quality data delivery within budget. Key duties include assessing new technologies, driving the creation and execution of system standards (SOPs), and overseeing user account administration across various platforms.